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Comparison of Rice Based-meal on Functional Constipation in Young Korean Women

Primary Purpose

Functional Constipation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Experimental Diet
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Functional Constipation focused on measuring Functional constipation, Brown rice based-meal, Polished rice based-meal, Wheat based-meal

Eligibility Criteria

19 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age of 19 to 30 years females
  • Meet of Rome Ⅲ diagnostic criteria of functional constipation
  • Ability to give informed consent

Exclusion Criteria:

  • Subject with a history or evidence of clinically significant gastrointestinal, anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric, cardiovascular disease
  • Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
  • Known history of moderate to severe hepatic impairment (i.e., serum ALT>1.5×ULN, AST>1.5×ULN)
  • Subjects with significant hypersensitivity about brown rice, polished rice, wheat, milk
  • Regular ingestion of probiotic products
  • Subjects who received certain medications that cause the alteration of bowel movement within the past 2weeks prior to first administration
  • Subjects who participated in other clinical investigation within 2 months prior to first administration
  • Subject who drink constantly (21 units/week over)
  • Subject who are pregnant or breast feeding
  • Subject who have irritable bowel syndrome by ROME Ⅲ criteria
  • Any significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study(i.e., laboratory test and others)

Sites / Locations

  • Clinical Trial Center for Functional Foods

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Brown Rice Based-Meal

Polished Rice Based-Meal

Wheat Based-Meal

Arm Description

Macronutrient composition of experimental diet were carbohydrate 55~70%, protein 7~20%, fat 15~25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women

Macronutrient composition of experimental diet were carbohydrate 55~70%, protein 7~20%, fat 15~25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women

Macronutrient composition of experimental diet were carbohydrate 55~70%, protein 7~20%, fat 15~25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women

Outcomes

Primary Outcome Measures

Total colon transit time
Hour of total colonic transit

Secondary Outcome Measures

Stool frequency
Frequency of stool(week)
Fecal weight
weight of fecal
Fecal pH
Fecal pH
Fecal lactic acid
Short chain fatty acid(lactic acid)
Fecal butyric acid
Short chain fatty acid
Fecal propionic acid
Short chain fatty acid
Fecal β-glucuronidase
Fecal enzyme
Fecal urease
Fecal enzyme
Fecal β-glucosidase
Fecal enzyme
Bowel movement
The bowel movement questionnire includes the defecation frequency, bowel time, fecal color, degree of difficulty in defecation and abdominal symptom

Full Information

First Posted
August 28, 2013
Last Updated
December 20, 2019
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01933100
Brief Title
Comparison of Rice Based-meal on Functional Constipation in Young Korean Women
Official Title
Comparison of Brown Rice Based-meal or Polished Rice Based-meal or Wheat Based-meal on Functional Constipation in Young Korean Women: A Opened, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study was conducted to investigate the effects of rice based-meal on functional constipation in young Korean women.
Detailed Description
Studies comparing and evaluating the effects of a rice-based diet and a wheat-based diet on bowel movements are insufficient. In summary, efficient measures are needed to help individuals consume enough dietary fiber from natural sources in daily life to improve their bowel movements, rather than to consume a fiber supplements separated or synthesized from a particular natural food. In this study, investigators compare and evaluate the effects and safety of eating rice-based diets (brown rice-based and white rice-based) and a wheat-based diet in terms of bowel health and bowel movements among young women with functional constipation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation
Keywords
Functional constipation, Brown rice based-meal, Polished rice based-meal, Wheat based-meal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brown Rice Based-Meal
Arm Type
Experimental
Arm Description
Macronutrient composition of experimental diet were carbohydrate 55~70%, protein 7~20%, fat 15~25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women
Arm Title
Polished Rice Based-Meal
Arm Type
Experimental
Arm Description
Macronutrient composition of experimental diet were carbohydrate 55~70%, protein 7~20%, fat 15~25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women
Arm Title
Wheat Based-Meal
Arm Type
Experimental
Arm Description
Macronutrient composition of experimental diet were carbohydrate 55~70%, protein 7~20%, fat 15~25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women
Intervention Type
Other
Intervention Name(s)
Experimental Diet
Intervention Description
Macronutrient composition of experimental diet were carbohydrate 55~70%, protein 7~20%, fat 15~25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women
Primary Outcome Measure Information:
Title
Total colon transit time
Description
Hour of total colonic transit
Time Frame
0, 28 days from the start of the study
Secondary Outcome Measure Information:
Title
Stool frequency
Description
Frequency of stool(week)
Time Frame
0, 28 days from the start of the study
Title
Fecal weight
Description
weight of fecal
Time Frame
0, 28 days from the start of the study
Title
Fecal pH
Description
Fecal pH
Time Frame
0, 28 days from the start of the study
Title
Fecal lactic acid
Description
Short chain fatty acid(lactic acid)
Time Frame
0, 28 days from the start of the study
Title
Fecal butyric acid
Description
Short chain fatty acid
Time Frame
0, 28 days from the start of the study
Title
Fecal propionic acid
Description
Short chain fatty acid
Time Frame
0, 28 days from the start of the study
Title
Fecal β-glucuronidase
Description
Fecal enzyme
Time Frame
0, 28 days from the start of the study
Title
Fecal urease
Description
Fecal enzyme
Time Frame
0, 28 days from the start of the study
Title
Fecal β-glucosidase
Description
Fecal enzyme
Time Frame
0, 28 days from the start of the study
Title
Bowel movement
Description
The bowel movement questionnire includes the defecation frequency, bowel time, fecal color, degree of difficulty in defecation and abdominal symptom
Time Frame
28 days from the start of the study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age of 19 to 30 years females Meet of Rome Ⅲ diagnostic criteria of functional constipation Ability to give informed consent Exclusion Criteria: Subject with a history or evidence of clinically significant gastrointestinal, anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric, cardiovascular disease Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery Known history of moderate to severe hepatic impairment (i.e., serum ALT>1.5×ULN, AST>1.5×ULN) Subjects with significant hypersensitivity about brown rice, polished rice, wheat, milk Regular ingestion of probiotic products Subjects who received certain medications that cause the alteration of bowel movement within the past 2weeks prior to first administration Subjects who participated in other clinical investigation within 2 months prior to first administration Subject who drink constantly (21 units/week over) Subject who are pregnant or breast feeding Subject who have irritable bowel syndrome by ROME Ⅲ criteria Any significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study(i.e., laboratory test and others)
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Rice Based-meal on Functional Constipation in Young Korean Women

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